Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201863657124 Date of Approval: 11/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of continuous erector spinae plane blocks for postoperative analgesia for living donor liver transplantation
Official scientific title Effectiveness of continuous erector spinae plane blocks for postoperative analgesia for living donor liver transplantation
Brief summary describing the background and objectives of the trial Erector spinae block (ESP) was first described in 2016 by Forero et al as a regional anesthetic technique. Local anesthetic injected into this erector spinae fascial plane spreads in a craniocaudal fashion over several levels and to the thoracic paravertebral space thereby targeting the dorsal and ventral rami of the spinal nerve. Thus it has the potential to provide both somatic and visceral sensory blockade, which would make it an ideal regional anesthetic technique for abdominal surgery. The significant advantages of ESP block compared to epidural or paravertebral block relate to the relative ease, simplicity, and safety of the block with fewer risks of pneumothorax. The use of an open surgical technique to identify the TAP accurately during the closure of the abdominal wall to perform regional anesthesia blocks and insert catheters for continuous analgesia was used by some investigators who stated that open TAP blocks are safe and reduce postoperative opioid requirements and sedation after liver resection and other surgeries as hemi‑colectomies, liver transplant, and emergency laparotomy, respectively. The primary goal of this study will be the comparison of the analgesic effect of ESP block and TAP block in living donor liver transplant. The secondary goal was to assess the total postoperative fentanyl consumption, postoperative nausea and vomiting, and time to first request for analgesia according to 10 cm VAS within 24h after surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2022
Actual trial start date
Anticipated date of last follow up 15/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ESP 20ml Bupivacaine 0.25% Every 8 hours boluses after the end of surgery bilateral Erector Spiane plane catheter insertion guided by ultrasound at the level of thoracic vertebrae (T 6-7). 25
Control Group TAP 20ml Bupivacaine 0.25% Every 8 hours boluses before the final closure of the abdomen two, an epidural catheter was placed under direct vision in the plane between transversus abdominis and internal oblique muscles and another between rectus abdominis muscle and the posterior wall of the rectus sheath 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all living donors for liver transplant Patient suffered from Major intraoperative events (e.g. severe hemodynamic instability, massive blood loss, massive blood products transfusion). Allergic patients to any of the study drugs Opioid addiction Body-mass index higher than 40 kg/m² unwilling to participate in the study Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/11/2021 IRB National Liver Institute Menoufia University
Ethics Committee Address
Street address City Postal code Country
Yassin Abdel Ghaffar Street fro mGamal Abdel Nasar Street Shebin Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analog scale VAS At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.
Secondary Outcome postoperative fentanyl consumption (µg) at 48 hours postoperative
Secondary Outcome postoperative nausea and vomiting at 48 hours postoperative
Secondary Outcome time to first request for analgesia according to 10 cm VAS within 24h after surgery
Primary Outcome Visual analog scale VAS At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.
Primary Outcome Analgesia Nociception Index ANI At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.
Secondary Outcome Mean Arterial Blood Pressure At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of surgery National liver institute Menoufia university Yassen abd elghaffar Shebin El Kom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nagwa Ibrahim Mowafy Yassen abd elghaffar Shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin Abdelghafar street from Gamal Abdel Nasser Street Sheben Elkom Menoufia governorate 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Menna Allah Aly ElShafie Yassin Abdel Ghaffar Street From Gamal Abdel Nassar Street Sheben ElKom 32511 Egypt
Nagwa ibrahim mowafy Yassin Abdel Ghaffar Street From Gamal Abdel Nassar Street Sheben ElKom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Menna elshafie menna80mas@gmail.com 00201112248935 Yassen abd elghaffar
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of anesthesia and Surgical Intensive Care National Liver Institute Menoufia University
Role Name Email Phone Street address
Principal Investigator Nagwa Mowafy Mowafynagwa@gmail.com 00201002773431 Yassen abd elghaffar
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of anesthesia and Surgical Intensive Care National Liver Institute Menoufia University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A full excel sheet of data will be available upon completing the recruitment Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/03/2025 Measured it in 9 time points Primary Outcome, Visual analog scale VAS, at 48 hours postoperative Primary Outcome, Visual analog scale VAS, At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/03/2025 Measured it in 9 time points Primary Outcome, Analgesia Nociception Index ANI, At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/03/2025 Measured it in 9 time points Secondary Outcome, Mean Arterial Blood Pressure, At baseline in the recovery area before discharge, two, six, 12, 18, 24, 30, 36, and 48 hours in the ICU.